Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in Patients Who Have Undergone Thyroid and Parathyroid Surgery Via the Transcutaneous Approach
NCT ID: NCT07173621
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
334 participants
INTERVENTIONAL
2025-10-01
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amnioeffect Application
AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.
Amnioeffect
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
No Amnioeffect Application
No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated
No interventions assigned to this group
Interventions
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Amnioeffect
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing thyroid/parathyroid surgery via a transcutaneous incision
* Participants must be willing and able to consent and take part in the study
Exclusion Criteria
* Pregnant patients
* Patients with a history of keloid scarring
* Patients who refuse blood products
* Previous neck surgery
* Patients on immunosuppressive medications (steroids, immune modulators, etc.)
* Patients with a known sensitivity to aminoglycoside antibiotics
* Patients with an active or latent infection
* Patients with a disorder that would create an unacceptable risk of post-operative complications
* Subjects may be excluded at the discretion of the physician(s) based on their clinical judgment and/or if the health or safety of the participant may be potentially impacted by taking part in this study
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Sarasota Memorial Health Care System
OTHER
Responsible Party
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Ralph Tufano
Principal Investigator
Locations
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Sarasota Memorial Health Care System
Sarasota, Florida, United States
Countries
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References
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Yilmaz S, Habibi HA, Yildiz A, Altunbas H. Thyroid Embolization for Nonsurgical Treatment of Nodular Goiter: A Single-Center Experience in 56 Consecutive Patients. J Vasc Interv Radiol. 2021 Oct;32(10):1449-1456. doi: 10.1016/j.jvir.2021.06.025. Epub 2021 Jul 10.
Watt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8.
Sonbol HS. Extracellular Matrix Remodeling in Human Disease. J Microsc Ultrastruct. 2018 Jul-Sep;6(3):123-128. doi: 10.4103/JMAU.JMAU_4_18.
Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40. doi: 10.1002/jbm.b.33265. Epub 2014 Aug 30.
Joshi CJ, Hassan A, Carabano M, Galiano RD. Up-to-date role of the dehydrated human amnion/chorion membrane (AMNIOFIX) for wound healing. Expert Opin Biol Ther. 2020 Oct;20(10):1125-1131. doi: 10.1080/14712598.2020.1787979. Epub 2020 Jul 20.
Dean DS, Gharib H. Epidemiology of thyroid nodules. Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):901-11. doi: 10.1016/j.beem.2008.09.019.
Cheng KL, Liang KW, Lee HL, Wang HY, Shen CY. Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach. Quant Imaging Med Surg. 2023 Aug 1;13(8):5355-5361. doi: 10.21037/qims-22-1385. Epub 2023 May 30.
Related Links
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AMNIOEFFECT PRODUCT BROCHURE
AMNIOEFFECT Application Guide
Processing
Spine and Neurosurgery
Other Identifiers
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25-SURG-34
Identifier Type: -
Identifier Source: org_study_id
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